
Isolab, Inc.
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HEMOCARD CONTROL HB-AA, AE, FAA, FAE is an FDA 510(k)-cleared medical device (K931234) manufactured by Isolab, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 10, 1993. Regulation: 8.